The Treatment of Transcranial Alternating Current Stimulation（tACS）on Patients With Cerebellar Ataxia: A Randomized, Triple-blind, Parallel-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- For Part Ⅰ (SCA3) -1
研究概览
简要总结
This is a longitudinal, triple-blind, randomized-controlled, prospective interventional study assessing patients with cerebellar ataxia, including spinocerebellar ataxia type 3 (SCA3) and multiple system atrophy-cerebellar type (MSA-C), to examine the efficacy, safety, and tolerability of transcranial alternating current stimulation (tACS) for up to 3 months.
详细描述
Transcranial alternating current stimulation (tACS) is a relatively recent method that noninvasively modulates brain oscillations, and can effectively stimulate deep brain regions, affect brain rhythm, increase neural plasticity, change neurotransmitter levels, and improve brain function. It is a comfortable, safe, effective, non-invasive, and easy-to-operate method, which means it has development potential in relevant medical fields. It has been approved by the FDA for clinically treating neuropsychiatric diseases.
This is a prospective, longitudinal, triple-blind, randomized-controlled, interventional study designed to evaluate the efficacy, safety, and tolerability of tACS in patients of SCA3 and MSA-C in China. Based on typical guidelines, we will use the tACS paradigm (bilateral mandible as a place for active electrode stimulation electrode, and the inion for the return electrode). This study has two parts. The patients studied in the Part Ⅰ are SCA3. The patients studied in the Part Ⅱ are MSA-C. Every part of study, subjects will be randomized into two groups, one receiving a 10-day (5 days/week for 2 weeks) treatment with real cerebellar tACS (CB-tACS) and the other receiving a sham stimulation. The patient's motor function, cognitive function, sleep, mental state, plantar pressure, and magnetic resonance imaging will be assessed before and after the intervention.
There will be a total of 4 visits. All patients receiving tACS will be visited face to face at baseline, day 1, day 30, and day 90 after the treatment begins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3
- •SCA3 patients aged 18 - 80 years
- •Patients or their family members have informed consent to the study and signed relevant documents
- •The pre-study ataxia Assessment Score (SARA) ranged from 3 to 30
- •for MSA-C
- •Aged 30-80 years
- •Diagnosed as clinically determined (Established)MSA-C or clinically Probable MSA-C according to the latest MSA diagnostic criteria
- •No more than 8 years after diagnosis of MSA-C
- •Able to walk independently or with assistance
- •Have a life expectancy of at least 3 years
- •Women of childbearing age with MSA need to use contraceptive measures
排除标准
- •Patients who have concomitant epilepsy.
- •Patients with a serious cognitive disorder, behavioral disorder, or mental illness
- •Patients with a history of seizures, stroke, encephalitis, or other degenerative neurological diseases
- •Patients with a serious medical disease
- •Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, or moderate or more severe liver disease
- •Patients with uncontrolled high blood pressure or diabetes
- •History of head injury or neurosurgical interventions.
- •History of any metal in the head (outside the mouth).
- •Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line), or any medical pumps.
- •Patients who have taken other investigational products within 4 weeks before being enrolled in this clinical trial, or patients who are pregnant or breastfeeding.
结局指标
主要结局
For Part Ⅰ (SCA3) -1
时间窗: Baseline - 2 weeks
To compare the proportion of patients with SARA improvement (decrease) of at least 1.5 from baseline after 2 weeks, assessing changes in the Assessment and Rating of Ataxia (SARA) Score.
For Part Ⅱ (MSA-C) -1
时间窗: Baseline - 2 weeks
Changes of Clinical Evaluation for (Unified Multiple System Atrophy Rating Scale) UMSARS improvement (decrease) from baseline to 2 weeks. UMSARS I: This is an assessment of daily life activities via 12 items scale used to assess language, writing, autonomy, walking, and the presence of possible urinary, sexual, or intestinal disorders. (0=no disorder, 48=severe) UMSARS II: Motor examination based on 14 items that evaluate particular facial expression, oculomotricity, oral expression, tremors, or walking. 0= no disorder, 56=severe disorders. UMSARS III: Blood pressure and heart rate measurements in lying and standing positions for 10 min every minute. UMSARS IV: Assessment of the disability from 1 to 5; 1 = completely independent; 5 = totally dependent.
次要结局
- For Part Ⅰ SCA3 -4(Baseline - 2 weeks - 1 month - 3 months)
- For Part Ⅱ MSA-C -2(1 month - 3 months)
- For Part Ⅰ SCA3 -3(Baseline - 2 weeks - 1 month - 3 months)
- For Part Ⅱ MSA-C -3(Baseline - 2 weeks - 1 month - 3 months)
- For Part Ⅱ MSA-C -4(Baseline - 2 weeks - 1 month - 3 months)
- For Part Ⅱ MSA-C -5(Baseline - 2 weeks - 1 month - 3 months)
- For Part Ⅰ SCA3 -2(1 month - 3 months)
- For Part Ⅱ MSA-C -6(Baseline - 2 weeks - 1 month - 3 months)
研究者
Ning Wang, MD., PhD.
Director
First Affiliated Hospital of Fujian Medical University